More than 6,500 of Jergens Inc.’s workholding products are now available on MachiningCloud. The integration will help Jergens’ customers increase productivity by providing instant access to up-to-date 3D CAD models for workholding products.
MTConnect Institute accredited as ANSI standards developer
The MTConnect Institute has been accepted as an accredited standards developer under the American National Standards Institute (ANSI). To align MTConnect procedures with ANSI, the Technical Advisory Group (TAG) has been re-established as the Standards Committee, responsible for developing and approving the standard.
“MTConnect is an industry effort and the standard only gets produced thanks to those companies and individuals volunteering their time to standard development,” says Tim Shinbara, secretary and treasurer of the MTConnect Institute and vice president of technology at AMT – The Association For Manufacturing Technology.
Methods Machine Tools’ director of financial services
Previously, Sheehan was vice president/relationship manager at U.S. Bank Equipment Finance for more than 10 years. In this role, he was in the Manufacturing Vendor Services Group and worked closely with Methods as a key lending partner.
5 factors for designing surgical instruments
Features - Cover Story
Metaphase Design Group strategies refine the creation process for surgical tools.
All fingertip touch points on Zimmer’s Persona knee implant alignment guide provide unambiguous visual cues on where and how to interact, combined with textures that telegraph through the surgeon’s gloved hand for precise non-slip control.
The best hand-operated surgical instruments make surgeons better at what they do. They should feel confident using them, like seamless extensions of their hands.
Metaphase Design Group specializes in research, ergonomics, and design of hand-intensive products with 70% of their offerings in the medical domain.
The company also works in other industries involving handheld products such as McDonalds, Revlon, and LG. The company enters the design process when a customer wants to create the next generation of a current product or when a research and design team has a prototype that needs ergonomic detailing.
Whether working on a medical handheld instrument or tweezers, Metaphase approaches all tasks the same way.
They identify the task, develop ways to improve it, and follow CEO Bryce Rutter’s five factors of success.
1. High functioning team
Before brainstorming and designing begins, a core team must be established. Each member should have a collaborative personality and an open mind. The team should have representation from mechanical engineering, brand and marketing, manufacturing, industrial design, and human factors engineering
.
Rutter says it is important to have perspectives from all of these groups, because input will be needed from each topic throughout the design process.
“Whatever you’re going to design is going to have an impact or need some information from these types of people in order to make the design successful and intuitive,” Rutter says.
2. User-centered strategy
The team should adopt a strategy based entirely on the user and the task at hand. Form follows function.
“You could have the coolest tech in the world, but if the design is not ergonomic, then the person using it is not going to access all the cool technology that’s available,” Rutter says.
Each design decision should be based on if it adds value, utility, or enhances user performance. Discovering performance and ergonomic requirements while conforming to user capabilities will guide design strategies.
3. Understand the users
To create a user-centered strategy, teams must understand the users. In design, a user is anyone who touches the product, including surgeons, surgical assistants, and nurses, and those responsible for cleaning. The team must learn how the target user thinks, feels, and behaves, as well as the person’s performance limits and capabilities.
“We do a lot of usability testing, we do a lot of user experience mapping, and we’re trying to identify the pain points and the current user experience, and that will tell us where we really need to focus,” Rutter says.
When conducting user research, do not rely entirely on interviews. Conducting time motion studies in surgery is key to understanding user behavior patterns. This includes disruptions, time on task, and pathways each team member takes while in the room during the surgery. Whether it’s picking up a tool or walking to a device, charting these factors leads to designing products and room layouts that can minimize surgical time and increase accuracy of the task. In these studies, surgical team members are asked to talk through what they are doing and experiencing during the procedure, illuminating meaningful insights into their challenges and what would make the surgery easier.
“That’s where you have big ‘aha’ moments to change the design in a significant and meaningful way,” Rutter adds.
Power grip affords the highest sustained downward blade forces and the most stable grip to prevent the micro saw from walking and skipping across bone.Medtronic’s M5 Microdebrider is designed for a high dexterity trilateral grip where the middle finger opposes the thumb providing the grip security, freeing the index finger to operate the rotary control for the cutting window.
4. Hand factors
The variety of human hands make designing the perfect surgical instruments challenging. To accommodate a mass market, designers target a range from the 5th female percentile (159mm to 160mm hand length) to the 95th male percentile (205mm to 209mm hand length).
“It sounds like a tall order. When you’re looking at differences, hand length or hand breadth, you’re not talking about six inches of difference, you’re talking about maybe a half an inch or an inch,” Rutter says. “So it’s not huge differences, however, those minute differences significantly impact the design and ability to scale the product to be a perfect fit. To get the product right, scale of the product is probably the most critical in ergonomics.”
Larger hands with bigger muscles are stronger than smaller hands. The muscles used in handling an instrument directly affect dexterity, precision, and control. Smaller muscles in the hands and fingers offer the most precision, control, and dexterity, while the larger muscles in the forearm and upper arm provide more strength. These factors, along with natural hand motions, determine where fingertip grip surfaces and controls should be located for optimum precision, control, and comfort.
In addition to hand size, age is also a factor to consider. People who are 45 years and older commonly experience diminished hand function. This includes reduced dexterity and weakening changes in hand-eye coordination, finger strength, and range of motion.
“The age of the user changes the definition of the user requirements,” Rutter says. “When you need to accommodate all hands, it’s more challenging to design a product that is all-encompassing.”
Weight and balance are two key physical attributes to consider when designing, regardless of user age. The center of mass and the instrument’s weight directly impact precision, dexterity, comfort, and manipulation of the instrument.
5. Design-thinking strategy
A design-thinking strategy must be applied to the entire eco-system of a product. This includes all touch points and how the product interacts with adjacent devices used in the surgical procedure. In design, three concepts are developed to test with targeted users that range from close-in, evolutionary improvements to revolutionary designs. The next step is refining those down to the best design strategy to take, focusing on ergonomic, design, and usability optimizations. The final design is then tested with end users to validate, and make tweaks as needed before the launch of the product.
“These five critical success factors will consistently lead to a framework for developing products that create demand, drive innovation, and increase revenues,” Rutter concludes.
About the author: Mary Puzder is an editorial intern for Today’s Medical Developments magazine. Contact Editor Elizabeth Engler Modic at 216.393.0234 or emodic@gie.net with any questions.
Products, technology, software, advancements
Departments - Products + Technology
Tool data management solutions; Single setup micro tap grinding; Tightening fixture; Coating system; Automatic measurement app; Clean room presses; Compact VMC; Coolant-through micro toolholders; Rigid ER collet chucks; Gundrilling machine; Laser measurement system; Tool grinder
The TapXmicro grinds taps up to M3. Based off the MX Linear machine platform, the 5-axis machine includes features to support each grinding operation – capacity for up to 6 wheel packs, dressers for all grinding wheels, and a flexible compensating chuck system between center workholding. TapXmicro delivers consistency when grinding micro tolerances, achieving a pitch diameter 1.5CpK when batch grinding M1.4 x 0.3mm taps with a tolerance of ±7µm.
Torque Fit is a tightening fixture for collet chucks with an integrated torque measuring system, ensuring proper tightening for high-precision cutting. An audible signal notifies user of correctly set torque values. Overtightening triggers LED error flashes.
Torque Fit replaces multiple torque wrenches and has adapters available for common machine tool interfaces such as CAT, BT, SK, HSK, and Big Capto. Torque values are preset, however, the operator can use a generic setting to tighten any collet chuck with a torque value up to 80Nm (60 lb-ft).
The VT-3000i system deposits various materials using physical vapor deposition (PVD) or plasma-enhanced chemical vapor deposition (PE-CVD). For temperature-sensitive substrates, it can use low-temperature arc vapor deposition technology (LTAVD). Deposition options include metallic colors – chrome, black, gold, brass, nickel, or bronze, as well as diamond-like carbon (DLC) – and various functional coatings.
VT-3000i’s 40% smaller footprint and updated design makes it easier to integrate into manufacturing facilities. The system eliminates complexities and increases ease of installation, operation, and maintenance.
Offering standard imaging and viewing features, the Omni Core digital inspection system can be user-customized via optional imaging and measurement apps. The 2D Automatic Measurement app analyzes samples requiring accurate and repeatable measurements. The app can take a single measurement or execute a menu of predetermined measurements – exporting the results for documentation and analysis.
The DNM 4000 vertical machining center for lean cell applications machines small parts in tough-to-machine materials. Featuring a 12,000rpm, 25hp, 40-taper spindle with 86 lb-ft of torque and a standard Big-Plus dual-contact interface, the DNM 4000 delivers short cycle times, consistent part surface finishes, and long tool life.
With a 65" x 11" x 108" footprint and travels of 20.5", 15.7", and 18.9" (X, Y, Z), the two-door design incorporates a large opening for easy access. The coolant system is located in the rear of the machine. The Fanuc i control with easy operation package (EOP) software developed by Doosan provides functions for convenient operation and reduced setup time.
With micro tools operating at higher speeds in more compact tooling zones, Ti-Loc micro end mill holders improve machining efficiency while extending tool life. Featuring coolant delivery ports surrounding the micro tool for optimum edge cooling and chip evacuation, Ti-Loc is compatible with coolant-thru live tooling or coolant-fed ER nuts for plumbing to high-pressure coolant delivery systems.
Available with a Jacobs taper #1, #2, #33, and #4, these holders are compatible with standard Jacobs taper spindles and accept standard ER collets. The chucks are available in ER16, ER20, and ER32. Specials are available to meet customer-specific needs.
The Eldorado M75-30T twin-spindle gundrilling machine’s counter-rotation fixture maximizes effectiveness of gundrilling by rotating the workpiece in the opposite direction of the drill’s rotation, improving straightness and reducing drill drift. The counter-rotation fixture features an improved gearbox and motor mount for reduced vibration. An automatic advance/retract of the entire counter-rotation assembly via a programmable servo simplifies part loading and unloading and reducing cycle time.
The M75-30T has a 0.75" (19mm) diameter drilling capacity and a 30" (762mm) maximum drilling depth. It has two gundrilling spindles using independent spindle control, enabling two independent drilling cycles at the same time.
The versatile Star NXT CNC 5-axis tool grinder with fewer moving parts has a small footprint and large grind zone to run small and large diameter wheels. It features easily configurable options in a modular design.
Features include: 28kW synchronous spindle at 20,000rpm; up to 250mm diameter tools; advanced linear, rotary torque motor technology to eliminate backlash, friction effects, drive vibration; Fanuc robot automation with 3mm to 38mm gripper assembly; and NUMROTO-plus grinding software.
The 2 Rod Auto-Cut CNC carbide cut-off machine automatically cuts carbide rods into precision lengths. Designed for cutting tool manufacturers and carbide rod processors, this machine’s large capacity magazine and automatic loader provides hours of unattended operation.
The cut-off machine can double the carbide cutting and hardened steel rod production rates of manual cut-off machines. Simple CNC controls with a touchscreen operator interface allow quick parameter setting for rod diameter and length. The machine automatically loads and cuts rods from a large capacity magazine.
Linak LC3, 3-stage lifting column provides quiet, powerful, and safe movement to operating tables, surgery chairs, and X-Ray equipment. It offers high bending moment, speeds up to 29mm/s, noise level less than 50dB, and a safety factor of 5.
Its bending moment makes it suitable for applications with large off-center loads that require solid and stable movement. Push versions range from 4,000N, to 6,000N and pull versions up to 4,000N.
It is available in two versions with a minimum built-in dimension of 320mm (standard) and a 440mm version for heavy-duty performance. Both versions easily integrate the column into applications. More than 30 combinations of cables through the column are available.
Festo Experience Center
Festo has opened its first North American Festo Experience Center in Santa Clara, California. The 5,000ft2 facility’s demonstration hall features augmented reality devices that allow visitors to virtually experience manufacturing and processing systems.
Rotating exhibits showcase active and static displays of the latest automated manufacturing and processing solutions. The center also includes a laboratory for focused customer solutions and training and meeting areas.
Digital amplifiers
Atlas digital amplifiers from PMD Corp. are single-axis modules with torque control of DC brush, brushless DC, and step motors. Amplifiers are used with third-party microprocessors or field programmable gate arrays (FPGAs) via serial peripheral interface (SPI) communications.
Versions are available in 75W, 250W, and 500W power configurations in two module sizes: 27mm x 27mm x 13mm and 39mm x 39mm x 15mm.
Amplifiers provide automatic protection from over-current, under-voltage, over-voltage, over-temperature, and short-circuit faults. Other features include programmable gain parameters and performance trace.
CE Mark approvals; FDA approvals
Departments - Regulatory
News from Guided Therapy Systems, Cerenovus, REVA Medical, and 7D Surgical.
Guided Therapy Systems’ Actisound intense therapeutic ultrasound works as an invisible scalpel, delivering small, thermal ablations beneath the skin to soft tissue – at the point of injury, up to 15mm deep without the need for surgery – promoting collagen growth and regenerating connective tissue.
Cerenovus’ Bravo Flow Diverter is approved for treatment of intracranial aneurysms. The device diverts blood flow from the aneurysm and promotes healing, reducing the risk of rupture. Early evaluations are scheduled across Europe ahead of European commercialization. The device is not approved for use in the U.S.
REVA Medical’s MOTIV is the first drug-eluting bioresorbable scaffold to receive CE Mark approval for treatment of below-the-knee peripheral artery disease. MOTIV is made from REVA’s vascular polymer scaffold Tyrocore. Radiopaque, MOTIV is visible under X-ray, helping ensure accurate placement in the artery.
Cranial module FDA approved
7DSurgical received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Cranial Module of the Machine-vision Image Guided Surgery (MvIGS) system for cranial surgery.
The system uses camera-based technology and machine vision algorithms to eliminate long-standing frustrations with legacy surgical navigational platforms. Using a contactless workflow, MvIGS acquires hundreds of thousands of virtual fiducials using the patient’s anatomy, resulting in nearly instantaneous cranial registration in almost any surgical position.
The Cranial Module can also register multiple datasets independently to the intra-operatively acquired Flashä regis- tration, allowing surgeons to visualize the anatomy on the fly.
Poll
What are the biggest challenges you see the medical device manufacturing industry facing in 2019?
